Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy

August 20, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

RAMP (Remote Activity Monitoring Pilot): A Feasibility Study Investigating Daily Step and Sleep Data in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Head and Neck Cancer

This pilot trial studies remote activity monitored by Fitbit Charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. A wearable remote activity tracking device, such as the Fitbit Charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC).

SECONDARY OBJECTIVES:

I. Evaluate feasibility of recruitment to the Remote Activity Monitoring Pilot (RAMP).

II. Investigate patient acceptability of RAM. III. Evaluate compliance with electronic patient-reported outcomes (ePROs) in this patient population.

IV. Estimate the change in average daily steps associated with a one-unit change in health score as collected on ePRO analysis (analyze associations between RAM data and ePROs).

V. Investigate correlations among step data, quality of life (QOL), and emergency room (ER) visits/hospitalizations.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects have head and neck cancer as defined in history and physical
  • Patients are eligible to be treated with RT or CRT and plan to start treatment
  • Patients are capable of giving informed consent
  • Patients must be able to read and/or to speak English
  • Patients who are 18 years of age or older
  • Women of reproductive potential should have a negative serum or urine pregnancy test within the week prior to radiation CT planning scan

Exclusion Criteria:

  • Patients who cannot read or speak English
  • Patients who are not candidates for RT/CRT treatment.
  • Women of childbearing potential who are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device Feasibility (Fitbit Charge 3)
Participants wear the Fitbit Charge 3 device from the time of CT simulation for RT planning throughout the entire RT course.
Device: Monitoring Device
Wear Fitbit Charge 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time patients wear the Fitbit Charge 3 device (compliance)
Time Frame: Through study completion, an average of 3 months
Daily compliance with remote activity monitoring (RAM) will be defined as wearing the device for 19/24 hours daily (80% daily use). Overall study period compliance will be defined as usage of the device for at least 70% of the days under observation where it should have been worn. The overall study period compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Voichita Bar-Ad, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

October 14, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17D.653
  • JT 10656 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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